In this episode of LifeSciences 360, we dive into the fascinating world of cell and gene therapy manufacturing with Carlos Yuraszeck. With over 16 years of experience, Carlos shares his deep insights into the unique challenges, opportunities, and innovations in the field, offering a detailed look into what it takes to bring life-saving therapies to patients. We cover everything from the design of manufacturing facilities to the complexities of quality systems, patient-centric innovations, and the future of allogeneic therapies.

If you're interested in the life sciences, cell and gene therapy, or just curious about cutting-edge advancements in medicine, this episode is for you!

Chapters:

00:00 - Intro  
00:02 - Understanding Cell and Gene Therapy Facilities  
00:09 - Challenges in Cell Therapy Facility Design  
00:26 - Automation in Manufacturing  
00:42 - Balancing Quality, Cost, and Time  
00:53 - Patient-Centric Manufacturing  
01:21 - Guest Introduction: Carlos Yuraszeck  
02:06 - Carlos’s Journey in Cell and Gene Therapy  
03:21 - Unique Factors in Facility Design  
04:14 - Making Facilities Operational  
05:09 - Subscription Appeal  
06:13 - Autologous vs. Allogeneic Cell Therapies Explained  
08:13 - Adjusting Processes Based on Patient Variability  
09:37 - Stem Cell Derived Therapies  
10:39 - Biotech Companies: Autologous or Allogeneic?  
12:07 - Strategic Decisions in Facility Design  
14:50 - Phase-Appropriate Quality Systems  
16:45 - Regulatory Flexibility and Urgency for Patients  
18:08 - Change Control in Early vs. Late Phases  
19:02 - Batch Records and Operator Judgment  
20:27 - Training Focus for Different Phases  
22:38 - Balancing Regulatory Requirements and Innovation  
24:32 - Risk Assessment Based on Patient Needs  
26:18 - The Potential of CAR T Therapies  
28:05 - The Allogeneic Space and Future Prospects  
31:00 - The Transformative Impact of Cell Therapy  
32:22 - Carlos’s Career Lessons and Fear of the Unknown  
34:45 - Closing Remarks and Subscription Reminder  
36:37 - Outro

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🔗 Links Mentioned:

Connect with Carlos on LinkedIn: 
https://www.linkedin.com/in/carlos-yuraszeck-5400091/


- Follow Life Sciences 360 on LinkedIn 
(https://www.linkedin.com/company/life-sciences-360)

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#Celltherapy #GMPoperations #executivedirector #astellaspharma #CellTherapyManufacturing #facilitydesign #DesigningCell

For transcripts, check out the podcast website - www.lifesciencespod.com